Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma

NCT01441973 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CA204-011
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 12

Brief Summary

The purpose of this study is to determine whether elotuzumab will improve response in patients with high risk smoldering myeloma who have more CD56\^dim cells (a marker for the health of the body's immune system)

Conditions

Smoldering Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Linear Regression of Maximal Percent Reduction in Serum Monoclonal (M) Protein on Baseline Percent CD56^Dim Cells in Bone Marrow

  Estimated using linear regression model, with baseline CD56\^dim cells as the independent covariate, and maximal percent reduction in serum M protein as the dependent variable. For 1 patient who had nonmeasurable disease at baseline, the percent change in serum kappa-lambda difference was used instead of the percent change in serum M protein. Unit of measure=percent change from baseline in M protein cells/ percent change in CD56\^dim cells (% chg from BL in M pro/% chg CD56\^dim cs)

  From day of last patient, first dose to 6 months

Secondary Outcomes (5)

• Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions

  From day of last patient, first dose to 6 months

• Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality

  From date of first dose to date of last dose plus 60 days (assessed up to August 2017, approximately 59 months

• Number of Participants With a Dose- or Concentration-related Effect on QTcF Interval, PR Interval, QRS Interval, and Heart Rate

  cycle 1 to first day of cycle 3 assessed up to 08/17, approximately 59 months

• Progression Free Survival (PFS) Rate

  Up to 2 years from the initiation of study therapy by dose cohort (approximately 24 months)

• Objective Response Rate (ORR)

  From first dose to date of progression or objective response (assessed up to August 2017, approximately 59 months)

Study Arms (2)

Elotuzumab, 20 mg/kg

EXPERIMENTAL

Intravenous solution administered in 28-day cycles. Cycle 1: Days 1 and 8. Cycle 2 and beyond: Day 1 only.

Biological: Elotuzumab (BMS-901608; HuLuc63)

Elotuzumab, 10 mg/kg

EXPERIMENTAL

Intravenous solution administered in 28-day cycles. Cycle 1 and 2: Days 1, 8, 15, and 22. Cycle 3 and beyond: Days 1 and 15.

Biological: Elotuzumab (BMS-901608; HuLuc63)

Interventions

Elotuzumab (BMS-901608; HuLuc63) BIOLOGICAL

Elotuzumab, 10 mg/kg; Elotuzumab, 20 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with a confirmed diagnosis, according to criteria of the International Myeloma Working Group, of smoldering multiple myeloma, considered high risk according to the following:
• Serum monoclonal (M) protein ≥3 gm/dL and bone marrow plasma cells (BMPC) ≥10% or
• Serum M protein 1-3 g/dL and BMPC ≥10% and abnormal free light chain ratio of \<0.125 or \>8.0
• Urine M protein \>200 mg/24 hours, ≥10% BMPC, and serum free light chain ratio ≤0.125 or ≥8.0

You may not qualify if:

• Active multiple myeloma
• Monoclonal gammopathy of undetermined significance
• Active plasma cell leukemia
• Positive for hepatitis B or C virus or HIV infection

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• AbbVie: collaborator

Study Sites (12)

Sharp Clinical Oncology Research

San Diego, California, 92123, United States

Location

Yale University School Of Medicine

New Haven, Connecticut, 06520, United States

Location

Va Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

Winship Cancer Institute.

Atlanta, Georgia, 30322, United States

Location

University Of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Investigative Clinical Research Of Indiana, Llc

Indianapolis, Indiana, 46260, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Washington University School Of Medicine

St Louis, Missouri, 63110, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Mid Dakota Clinic, Pc

Bismarck, North Dakota, 58501, United States

Location

Related Links

• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form

MeSH Terms

Conditions

Smoldering Multiple Myeloma

Interventions

elotuzumab

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Hypergammaglobulinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Paraproteinemias; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2011
• First Posted: September 28, 2011
• Study Start: December 28, 2011
• Primary Completion: May 30, 2014
• Study Completion: January 17, 2017
• Last Updated: January 23, 2018
• Results First Posted: January 29, 2016

Record last verified: 2017-12

Locations

US (12)